Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus (FumaCLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT01352988
First received: April 29, 2011
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to evaluate the therapeutic effect of fumaric acid esters (Fumaderm®) in the treatment of Cutaneous Lupus Erythematosus with respect to proportion of responders based on the Revised Cutaneous Lupus Disease Area and Severity Index (RCLASI) activity score for skin lesions at baseline and after 24 weeks of treatment or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF).


Condition Intervention Phase
Lupus Erythematosus, Cutaneous
Drug: Fumaric acid esters
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fumaric Acid Esters (Fumaderm®) in the Treatment of Patients With Cutaneous Lupus Erythematosus: A Mono-Centre, Open-Label, Prospective Pilot Study

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Primary efficacy outcome is the response rate at week 24 or at the latest assessment for patients who withdrew prematurely. [ Time Frame: Week 24 or at the latest assessment for patients who withdrew prematurely (Last Observation Carried Forward, LOCF). ] [ Designated as safety issue: No ]
    Response is defined as a reduction of 50% in the total RCLASI activity for skin lesions, compared to the baseline value ("RCLASI 50").


Secondary Outcome Measures:
  • Proportion of patients with RCLASI 50 at week 12 of treatment [ Time Frame: Week 12 of treatment ] [ Designated as safety issue: No ]
  • Proportion of patients with at least partial response at end of therapy (with regard to RCLASI activity score for skin lesions) [ Time Frame: End of therapy (up to 24 weeks) ] [ Designated as safety issue: No ]
  • Time from start of treatment to first RCLASI 50 assessment (time to response). [ Time Frame: Time to response (up to 24 weeks) ] [ Designated as safety issue: No ]
  • Patient's global assessment and VAS for itch and pain 12 weeks after the beginning of treatment and at the end of therapy. [ Time Frame: 12 weeks after the beginning of treatment and at the end of therapy (up to 24 weeks). ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events (AEs) and their severity. [ Time Frame: 24 weeks of treatment + 4 weeks of follow up ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: July 2011
Study Completion Date: February 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fumaric acid esters Drug: Fumaric acid esters
Starting from 1 tablet Fumaderm® initial per day, with titration up to 6 tablets Fumaderm® per day; in case of side effects, the dose will be adapted to the highest tolerable levels
Other Names:
  • Fumaderm® initial
  • Fumaderm®

Detailed Description:

At screening, patients meeting the inclusion and exclusion criteria will be asked to provide written informed consent. Male patients and female patients without childbearing potential will also complete other screening procedures including vital signs, physical examination, and patients and physicians efficacy assessments.

Treatment will be started as soon as possible after screening and not later than 1 month after screening.

The patients will receive a treatment either with Fumaderm® initial and/or Fumaderm® enteric-coated tablets. Fumaderm® initial will be usually administered during the first three weeks of treatment and / or during the trial when adaptation of the daily dosage will be required due to the occurrence of adverse reactions, e.g gastrointestinal.

Throughout the trial, daily use of sunscreens (sun protection factor, SPF≥50) will be recommended to all patients. The management of CLE may also involve the use of topical medications, such as topical steroids, or systemic rescue medications, such as antimalarials.

All patients will be evaluated with the RCLASI, PAGI and VAS after 12 weeks and at the end of treatment. Adverse Events (AE) will be recorded at each visit until 4 weeks after the end of therapy. Serious Adverse Events (SAE) must be reported if they occur up to 4 weeks after the end of therapy.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical and histological diagnosis of CLE (DLE, SCLE, LET, without major systemic involvement) who failed to response to topical corticosteroids;
  • Total RCLASI activity score of >6 (at least 3 points in at least 2 locations) on an assessment of erythema, scale/hyperkeratosis, edema/infiltration and subcutaneous nodule/plaque of the lesion (mucous membrane lesions/alopecia excluded);
  • Women of childbearing potential must agree to use at least one primary method of contraception and preferably, at the same time, a secondary method of contraception from the time of screening, throughout trial treatment, and for at least one month after finishing treatment.
  • Signed informed consent.

Exclusion Criteria:

  • Patients unable to comply with the requirements of the study;
  • Only scarred cutaneous target lesions without activity;
  • Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease;
  • Active skin disease other than CLE or another progressive or serious disease that interferes with the study outcome;
  • Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
  • Active severe infection diseases, including chronic or localized;
  • Known malignancies in the last 5 years, other than effective treated non melanoma skin cancer;
  • Severe liver- or kidney- disease;
  • Severe gastrointestinal disease, like gastric or duodenal ulcer;
  • Severe hematologic disorders;
  • Patients with leucopenia (<3.000/mm³);
  • Patients with lymphopenia (<500/mm³);
  • Patients with known hypersensitivity to fumaric acid esters or their derivatives, or to any study medication components;
  • Topical corticosteroids within 14 days prior to dosing;
  • Local treatment with fumaric acid derivates;
  • Initiation or change in the dose of any current systemic medication for the treatment of CLE/SLE prior to the study (time depending on drug class);
  • Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study;
  • Concomitant treatment with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolbutamide;
  • Drugs associated to CLE-induction: terbinafine, hydrochlorothiazide, diltiazem, verapamil, nifedipine, nitrendipine, fluorouracil, penicillamine, infliximab, adalimumab, etanercept, pantoprazole;
  • Drugs interfering/ interacting with fumaric acid esters;
  • Drugs with nephrotoxic potential, e.g. retinoids, psoralens, methotrexate, cyclosporine, immunosuppressants, cytostatics;
  • Participation in another clinical trial including the four week period preceding the study or having received a non-licensed drug within the last 3 months prior to the study;
  • Pregnancy (according to pregnancy test) or nursing.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352988

Locations
Germany
Department of Dermatology, University Hospital Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Annegret Kuhn, Prof. Dr. Department of Dermatology, University Hospital Muenster
  More Information

No publications provided

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT01352988     History of Changes
Other Study ID Numbers: UKM 10_0020
Study First Received: April 29, 2011
Last Updated: February 27, 2014
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
C17.300.475
C17.800.480

Additional relevant MeSH terms:
Lupus Erythematosus, Cutaneous
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl fumarate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 23, 2014